Putting QbD into practice
Lilly have provided an good insight into their implementation of QbD within their manufacturing processes. continuous manufacturing has been well established for years in food and medical device industries so it is about time the Pharma industry caught up.
Eye Drop recall (FDA)
A recall following mould being discovered within sterile eye drops. There are concerns that the preservative fails to protect the product during its in-use shelf life. This should prompt you to check the preservative efficacy testing methods and limits for different dosage forms. It is also worth thinking about possible causes for the lack of efficacy of the preservative such as; increased bioburden of raw materials; change in primary container plastic causing preservative adsorption; pH change of formulation; container integrity fail etc
Motrin Recall (FDA)
A recall of an infant oral formulation due to a risk of particulate contamination in the API.
Micro website
A useful website for your microbiology revision. There is a popular forum for which to post your questions.
Monoclonal Antibody Stability
This website is a good resource for the stability of monoclonals when compounded into ready to administer formulations. It is useful to know how your MAbs are being used within 'specials' compounders and their take on stability studies. It is also a good opportunity to compare the ICH stability requirements versus the information within this website.
PQG QP seminar
A reminder of the PQG QP seminar on 16th October. These seminars are an excellent introduction to QP training, scenarios and the all important networking. I'll be attending so hopefully I'll see you there!
Happy Reading!
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